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Strategy is not something often associated with compliance operations or activities. In fact, compliance is virtually never considered strategically, and certainly the design of compliance functions, staff models, document systems, computer operations, etc. are not designed strategically. This is a major mistake on the part of most regulated enterprises.

How do you develop a world-class compliance strategy? Here are a few points to consider:

If you are an FDA-regulated company, it is likely that more than 80% of your business has extensive regulation. Weaving regulatory requirements, expectations and risk-tolerance together with your business objectives will help to ensure you have invested properly, understand your risks, and have taken the appropriate actions to protect your business for the future.

Most compliance activities have not been considered in a strategic review for fit to purpose, business supportive capability, or even appropriateness for risk-reduction. In fact, many executives have NO IDEA of how well performing their compliance functions are, and whether they are ready for the FDA or other regulatory body. This is astonishing considering upwards of 25% of operational fixed costs (CA estimate) can likely be attributed to regulatory compliance functions. Billions of industry dollars are spent each year on compliance operations, without high-level strategic integration and business support analysis. How can this be?

The compliance / enforcement record of FDA-regulated industry is abysmal! If we operated in the nuclear industry, the regular and consistent enforcement actions attributed to individual companies would be front page news in the Wall Street Journal! Yet, in FDA-regulated industry, we accept it as normal, and the cost of doing business. For companies committed to success, this enforcement track-record should not be acceptable.

Developing a compliance strategy is not hard — but it does take vision, knowledge, expertise, business acumen, and a commitment to excellence that is often lacking. We can help you ensure your compliance operations are strategically integrated into the your company’s long-term business success. Isn’t that the least your company deserves?